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Depression Decision Aid: Feasibility Pilot

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Completed
CT.gov ID
NCT02239367
Collaborator
National Institute of Mental Health (NIMH) (NIH)
18
Enrollment
1
Location
1
Arm
10.4
Actual Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this proposed pilot study is to test the feasibility and acceptability of a Depression Decision Aid (DDA) protocol integrated into the Electronic Health Record (EHR) and used by nurses with depressed ambulatory care patients. The Depression Decision Aid protocol is a streamlined adaptation of an in-person Shared Decision-Making (SDM) intervention, and its goal is to increase patient involvement in clinically appropriate treatment decision-making as a way of strengthening treatment engagement and outcomes. The protocol guides ambulatory care nurses in helping depressed patients (Patient Health Questionnaire-9 [PHQ-9] >10) develop informed treatment preferences through a process of education and values clarification. We will target patients in the general medical clinic, whether currently receiving depression treatment or not, because depression is highly prevalent but often poorly managed in this population.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Depression Decision Aid
 N/A

Detailed Description

The aims of this project are to evaluate the acceptability and feasibility of an electronic Depression Decision Aid protocol with nurses and patients using questionnaire and administrative data.

One to two nurses will deliver the Decision Aid protocol to 40 low-income patients (aged 21 and over) scoring >10 via routine PHQ-9 screening. Consenting nurses will be assessed regarding their satisfaction with the protocol following its use with each patient subject. Nurse fidelity to the protocol will be evaluated via their documentation of protocol use in the EHR. Consenting patient subjects will be assessed at baseline; week 1 to determine their decision about depression treatment, satisfaction with the decision-making process; and week 12 to determine treatment initiation or change, treatment adherence, and depressive status. Medical records will also be examined for documentation of medication prescription and other depression treatments.

The study will test the following hypothesis concerning the Depression Decision Aid protocol:
  1. Feasibility and Acceptability: a) At least 85% of each nurse's intervention sessions will meet fidelity standards via Electronic Health Record (EHR) data; b) Nurses will report high levels of satisfaction with the Decision Aid; c) Patients will report high levels of satisfaction with the decision-making process;

Study Design

Study Type:
Interventional
Actual Enrollment :
18 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Electronic Depression Decision Aid for Nurses in Primary Care: Development and Implementation in a Diverse Low-Income Population
Actual Study Start Date :
May 30, 2014
Actual Primary Completion Date :
Apr 13, 2015
Actual Study Completion Date :
Apr 13, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: Depression Decision Aid protocol

The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention. Shared decision-making, in contrast to traditional medical decision-making, involves a collaborative process where patients discuss personal values and preferences and clinicians provide information to arrive at an agreed upon treatment decision. The focus of the intervention is to empower the elderly depressed primary care patients and help them efficiently arrive at a treatment decision that can be successfully implemented.

Behavioral: Depression Decision Aid
The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention.
Other Names:
  • Shared Decision Making

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Use of Depression Decision Aid protocol [12 weeks]

      The number of nurse's intervention sessions based on Electronic Health Record data

    Secondary Outcome Measures

    1. Satisfaction with the Decision Aid Measure [12 weeks]

      The Nurse Satisfaction Scale includes a measure of usefulness, clarity, ease of use, and feasibility in terms of timing when using the Decision Aid.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 21 years and older

    • Medical outpatient presenting to the Lincoln Hospital ambulatory care clinic or geriatric sub-specialty clinic

    • Screen positive for depression (Patient Health Questionnaire-9 score of 10 or greater)

    Exclusion Criteria:

    • Presence of significant alcohol or substance abuse, psychotic disorder, or bipolar disorder

    • High suicide risk

    • Cognitive impairment: Mini Mental Status Exam (MMSE) score less than 24.

    • Acute or severe medical illness (ie. delirium, metastatic cancer, decompensated cardiac, liver, or kidney failure, major surgery, stroke, or myocardial infarction during the three months prior to entry.

    • Inability to speak English or Spanish

    • Aphasia interfering with communication

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Lincoln Hospital- the New York City Health and Hospitals Corporation (HHC) Bronx New York United States 10451

    Sponsors and Collaborators

    • Weill Medical College of Cornell University
    • National Institute of Mental Health (NIMH)

    Investigators

    • Principal Investigator: Patrick J Raue, Ph.D., Weill Medical College of Cornell University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Weill Medical College of Cornell University
    ClinicalTrials.gov Identifier:
    NCT02239367
    Other Study ID Numbers:
    • 1401014663
    • P30MH085943
    First Posted:
    Sep 12, 2014
    Last Update Posted:
    Jan 25, 2017
    Last Verified:
    Jan 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Depression
    Depressive Disorder

    Study Results

    No Results Posted as of Jan 25, 2017